ALGO 7i
K号: K211147 · 2021-10-14
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决定日期2021-10-14
产品代码GWJ
咨询委员会NE
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决定实质等同
器械摘要
ALGO 7i is the device name listed in this FDA 510(k) record. The listed applicant is Path Medical GmbH. It received FDA 510(k) clearance on 2021-10-14 under 510(k) number K211147. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ALGO 7i?
ALGO 7i is a medical device that received FDA 510(k) clearance on 2021-10-14. The listed applicant is Path Medical GmbH. The 510(k) number is K211147.
When did ALGO 7i receive FDA 510(k) clearance?
ALGO 7i received FDA 510(k) clearance on 2021-10-14, under 510(k) number K211147.
Who is the listed applicant for ALGO 7i?
The FDA 510(k) record lists Path Medical GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ALGO 7i?
The FDA product code for ALGO 7i is GWJ.
列明Path Medical GmbH为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：GWJ）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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